Patients with Advanced Metastatic FAP-Positive TumorsEarly Phase 1NCT06636617
177Lu-JH04 in Patients with FAP-Positive Tumors
A Early Phase 1 study testing 3.70 GBq (100 mCi) of 177Lu-JH04, 5.55 GBq (150 mCi) of 177Lu-JH04 and 7.40 GBq (200 mCi) of 177Lu-JH04 in people with Patients with Advanced Metastatic FAP-Positive Tumors, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
This is a pilot study to assess the dosimetry, toxicity and response of 177Lu-JH04, a new FAP-targeted radiopharmaceutical, in patients with FAP-Positive Tumors. All patients underwent 68Ga-FAPI PET/CT for selection and were successively divided into three groups of 3 people each.The three groups received successively… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients with Advanced Metastatic FAP-Positive Tumors
- What is being tested?
- 3.70 GBq (100 mCi) of 177Lu-JH04, 5.55 GBq (150 mCi) of 177Lu-JH04 and 7.40 GBq (200 mCi) of 177Lu-JH04
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2024to 31 Aug 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- progressive advanced metastatic tumors
- tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT
- adequate renal, haematological, and liver function
- an Eastern Cooperative Oncology Group performance status of 0-2
Who cannot join
- pregnant or lactating women
- received other radionuclide therapy in the past 6 months
- received chemotherapy, radiotherapy and other anti-tumor treatments in the past 28 days
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Weibing Miao, MD, +86-0591 87981618, miaoweibing@126.com
Guochang Wang, MD, +86-0591 87981619, guochang1007@163.com
About this study
Official title: Safety, Dosimetry and Treatment Response of 177Lu-JH04 in Patients with FAP-Positive Tumors
This is a pilot study to assess the dosimetry, toxicity and response of 177Lu-JH04, a new FAP-targeted radiopharmaceutical, in patients with FAP-Positive Tumors. All patients underwent 68Ga-FAPI PET/CT for selection and were successively divided into three groups of 3 people each.The three groups received successively an approximately 3.70 GBq (100 mCi), 5.55 GBq (150 mCi) and 7.40 GBq (200 mCi) of 177Lu-JH04 up to 4 cycles.
Read the detailed description
Cancer-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment and present abundantly in the stroma of multiple tumor entities. Fibroblast activation protein (FAP), as a specific marker protein of CAFs, is overexpressed on more than 90% of malignant tumors\& limited and expression in normal tissues, making it an appropriate target for diagnosis and therapy of numerous malignant tumors. Currently, several radiopharmaceuticals targeting FAP for radionuclide therapy have been developed, such as 177Lu-FAPI-46, 177Lu-FAP-2286, and showed high efficacy and reasonable toxicity profile in tumor treatment. 177Lu-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, we assess the dosimetry, toxicity and response of 177Lu-JH04 for the treatment of patients with advanced metastatic cancers after exhaustion of all other treatment options.
- Being tested
- 3.70 GBq (100 mCi) of 177Lu-JH04, 5.55 GBq (150 mCi) of 177Lu-JH04, 7.40 GBq (200 mCi) of 177Lu-JH04
- Keywords
- Lu-177, FAP, Tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3.70 GBq (100 mCi) of 177Lu-JH04Drug
All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04.
5.55 GBq (150 mCi) of 177Lu-JH04Drug
All 3 patients were intravenous injected with single 5.55 GBq (150 mCi) of 177Lu-JH04
7.40 GBq (200 mCi) of 177Lu-JH04Drug
All 3 patients were intravenous injected with single 7.40 GBq (200 mCi) of 177Lu-JH04
| Study group | Role | What they receive |
|---|---|---|
| 3.70 GBq (100 mCi) of 177Lu-JH04 | Experimental | All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04. Receives: Drug: 3.70 GBq (100 mCi) of 177Lu-JH04 |
| 5.55 GBq (150 mCi) of 177Lu-JH04 | Experimental | All 3 patients were intravenous injected with single dose 5.55 GBq (150 mCi) of 177Lu-JH04. Receives: Drug: 5.55 GBq (150 mCi) of 177Lu-JH04 |
| 7.40 GBq (200 mCi) of 177Lu-JH04 | Experimental | All 3 patients were intravenous injected with single dose 7.40 GBq (200 mCi) of 177Lu-JH04. Receives: Drug: 7.40 GBq (200 mCi) of 177Lu-JH04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxic and side effect
The white blood cell count, granulocyte count, platelet count, hemoglobin count and serum biochemicals of each patient before and after each treatment were recorded and compared. And the weight (in kilograms) of the patients was monitored. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
Measured: through study completion, an average of 2 weeks
Secondary outcomes (1)
Dosimetry of normal organs and tumors
The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-JH04. The dose delivered to normal organs and tumors will be recorded.
Measured: through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start21 Aug 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients with Advanced Metastatic FAP-Positive TumorsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weibing Miao, MD, Principal investigator, The First Affiliated Hospital, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636617
- Sponsor's protocol ID
- FirstAHFujian-177Lu-JH04
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Dosimetry and Treatment Response of 177Lu-JH04 in Patients with FAP-Positive Tumors
- ClinicalTrials.gov ID
- NCT06636617
- Acronym / sponsor ID
- FirstAHFujian-177Lu-JH04
- Keywords
- Lu-177, FAP, Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to assess the dosimetry, toxicity and response of 177Lu-JH04, a new FAP-targeted radiopharmaceutical, in patients with FAP-Positive Tumors. All patients underwent 68Ga-FAPI PET/CT for selection and were successively divided into three groups of 3 people each.The three groups received successively an approximately 3.70 GBq (100 mCi), 5.55 GBq (150 mCi) and 7.40 GBq (200 mCi) of 177Lu-JH04 up to 4 cycles.
Detailed description
Cancer-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment and present abundantly in the stroma of multiple tumor entities. Fibroblast activation protein (FAP), as a specific marker protein of CAFs, is overexpressed on more than 90% of malignant tumors\& limited and expression in normal tissues, making it an appropriate target for diagnosis and therapy of numerous malignant tumors. Currently, several radiopharmaceuticals targeting FAP for radionuclide therapy have been developed, such as 177Lu-FAPI-46, 177Lu-FAP-2286, and showed high efficacy and reasonable toxicity profile in tumor treatment. 177Lu-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, we assess the dosimetry, toxicity and response of 177Lu-JH04 for the treatment of patients with advanced metastatic cancers after exhaustion of all other treatment options.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3.70 GBq (100 mCi) of 177Lu-JH04 | Experimental | Drug: 3.70 GBq (100 mCi) of 177Lu-JH04All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04. |
| 5.55 GBq (150 mCi) of 177Lu-JH04 | Experimental | Drug: 5.55 GBq (150 mCi) of 177Lu-JH04All 3 patients were intravenous injected with single dose 5.55 GBq (150 mCi) of 177Lu-JH04. |
| 7.40 GBq (200 mCi) of 177Lu-JH04 | Experimental | Drug: 7.40 GBq (200 mCi) of 177Lu-JH04All 3 patients were intravenous injected with single dose 7.40 GBq (200 mCi) of 177Lu-JH04. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- progressive advanced metastatic tumors
- tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT
- adequate renal, haematological, and liver function
- an Eastern Cooperative Oncology Group performance status of 0-2
Key exclusion criteria (3 listed)
- pregnant or lactating women
- received other radionuclide therapy in the past 6 months
- received chemotherapy, radiotherapy and other anti-tumor treatments in the past 28 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3.70 GBq (100 mCi) of 177Lu-JH04All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04. | Drug | 3.70 GBq (100 mCi) of 177Lu-JH04 |
| 5.55 GBq (150 mCi) of 177Lu-JH04All 3 patients were intravenous injected with single 5.55 GBq (150 mCi) of 177Lu-JH04 | Drug | 5.55 GBq (150 mCi) of 177Lu-JH04 |
| 7.40 GBq (200 mCi) of 177Lu-JH04All 3 patients were intravenous injected with single 7.40 GBq (200 mCi) of 177Lu-JH04 | Drug | 7.40 GBq (200 mCi) of 177Lu-JH04 |
Primary outcome
Toxic and side effect
Time frame: through study completion, an average of 2 weeks
The white blood cell count, granulocyte count, platelet count, hemoglobin count and serum biochemicals of each patient before and after each treatment were recorded and compared. And the weight (in kilograms) of the patients was monitored. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
1 secondary outcome
Dosimetry of normal organs and tumors
Time frame: through study completion, an average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weibing Miao, MD principal investigator
The First Affiliated Hospital, Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 3.70 GBq (100 mCi) of 177Lu-JH04, 5.55 GBq (150 mCi) of 177Lu-JH04 and 7.40 GBq (200 mCi) of 177Lu-JH04 in people with Patients with Advanced Metastatic FAP-Positive Tumors, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weibing Miao, MD (+86-0591-87981618, miaoweibing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxic and side effect (time frame: through study completion, an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.